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NCT03262155 Clinical Trial

Study of Immunity Dysfunction Induced by Extracorporeal Assistance (ECMO / ECLS)

Acute Respiratory Distress Syndrome Clinical Trial

— IMPEC  

Official title:
Study of Immunity Dysfunction Induced by Extracorporeal Assistance (ECMO / ECLS)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03262155
Other study ID # 35RC16_3037_IMPECstudy
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date January 31, 2019

Study information
Verified date April 2023
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Study of immunosuppression biomarkers in patients with ARDS or cardiogenic shock with ECMO / ECLS, compared to patients with ARDS or cardiogenic shock without ECMO / ECLS

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date January 31, 2019
Est. primary completion date January 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient older than 18 years old - Patient hospitalized in an intensive care unit - Patient whose initial ARDS or Cardiogenic shock began less than 5 days before admission - Patients hospitalized for ARDS or Cardiogenic shock with ECMO / ECLS or - Patients hospitalized for ARDS or Cardiogenic shock without ECMO / ECLS Exclusion Criteria: - Opposition of patient, relative or legal representative for participation in the study - Pregnant woman - Pre-immunodepression - Implementation of immunosuppressive therapy such as chemotherapy, cyclophosphamide, high-dose corticosteroids (> 0.5mg / kg / day).

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Blood test

Locations
Country Name City State
France CHU de Rennes Rennes

Sponsors (1)
Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of immunosuppression in patients with ARDS or cardiogenic shock under ECMO / ECLS hospitalized in intensive care unit Hour 24
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